Approximately a quarter of the global population suffer from latent tuberculosis infection (LTBI) with tuberculosis (TB) accountable for more than 1.5 million deaths annually. An increased risk of TB and LTBI reactivation may be due to methotrexate, cyclosporine, and tumor necrosis factor inhibitors, although there are limited data on the risks of TB with use of newer biologics. A study published in JAMA Dermatology focused on assessing the association of secukinumab with reports of active TB development, TB reactivation, and LTBI activation as an adverse event (AE) in patients with psoriasis, psoriatic arthritis, or ankylosing spondylitis.
This cohort study pooled data from 28 clinical trials of secukinumab used to treat psoriasis (17 phase 3 or 3b and two phase 4 trials), psoriatic arthritis (five phase 3 trials), and ankylosing spondylitis (four phase 3 trials). A search was conducted within the Novartis Secukinumab Compound Pool Database for all 28 trials. All the trial participants who had received at least 1 approved subcutaneous dose of secukinumab (150 mg or 300 mg) were included. All patients were screened for TB prior to randomization in these trials. Therefore, any patients with active TB were excluded, and patients with LTBI were treated per the local guidelines. Data that were accrued from the start of treatment in the individual studies through December 25, 2018, were analyzed. Any reporting of active TB or LTBI as an AE over a 5-year period using exposure-adjusted incidence rates (EAIR; incidence rates per 100 patient-years).
According to the results, a total of 12,319 patients were included, of which 8819 patients had psoriasis (71.6%; 5930 men [67.2%]; mean [SD] age, of 44.9 [13.5] years), 2523 had psoriatic arthritis (20.5%; 1323 women [52.4%]; mean [SD] age, 48.8 [12.1] years), and 977 had ankylosing spondylitis (7.3%; 658 men [67.3%]; mean [SD] age, 42.3 [11.9] years). At screening, 684 patients (5.6%) tested positive for LTBI. Over 5 years, LTBI as an AE during secukinumab treatment was reported in 13 patients (0.1% of 12,319). Of these 13 patients, six had a prior positive LTBI test result, and seven were newly diagnosed as having LTBI. Within these seven, four had psoriasis (EAIR, 0.03; 95% CI, 0.01-0.07), one had psoriatic arthritis (EAIR, 0.02; 95% CI, 0.00-0.11), and two had ankylosing spondylitis (EAIR, 0.08; 95% CI, 0.01-0.28). There were no cases of active TB were reported.
The study concluded that LTBI reported as an AE after secukinumab treatment was uncommon and the results support the use of secukinumab in chronic systemic inflammatory conditions. —Jessica Garlewicz
Elewski BE, Baddley JW, Deodhar AA, et al. Association of secukinumab treatment with tuberculosis reactivation in patients with psoriasis, psoriatic arthritis, or ankylosing spondylitis. JAMA Dermatol. 2021;157(1):43-51. doi:10.1001/jamadermatol.2020.3257